Last update 25 Dec 2025

Daratumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Daratumumab (Genetical Recombination), 达拉图单抗, 达雷木单抗
+ [7]
Target
Action
inhibitors
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Nov 2015),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Smoldering Multiple Myeloma
European Union
24 Jul 2025
Smoldering Multiple Myeloma
Iceland
24 Jul 2025
Smoldering Multiple Myeloma
Liechtenstein
24 Jul 2025
Smoldering Multiple Myeloma
Norway
24 Jul 2025
Immunoglobulin Light-Chain Amyloidosis
European Union
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Iceland
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Liechtenstein
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Norway
20 May 2016
Refractory Multiple Myeloma
European Union
20 May 2016
Refractory Multiple Myeloma
Iceland
20 May 2016
Refractory Multiple Myeloma
Liechtenstein
20 May 2016
Refractory Multiple Myeloma
Norway
20 May 2016
Relapse multiple myeloma
European Union
20 May 2016
Relapse multiple myeloma
Iceland
20 May 2016
Relapse multiple myeloma
Liechtenstein
20 May 2016
Relapse multiple myeloma
Norway
20 May 2016
Multiple Myeloma
United States
16 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 3
United States
26 Apr 2019
Residual NeoplasmPhase 3
Canada
26 Apr 2019
AmyloidosisPhase 3
United States
10 Oct 2017
AmyloidosisPhase 3
United States
10 Oct 2017
AmyloidosisPhase 3
Japan
10 Oct 2017
AmyloidosisPhase 3
Japan
10 Oct 2017
AmyloidosisPhase 3
Australia
10 Oct 2017
AmyloidosisPhase 3
Australia
10 Oct 2017
AmyloidosisPhase 3
Belgium
10 Oct 2017
AmyloidosisPhase 3
Belgium
10 Oct 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
390
zdrzgifbmk(kvlrwshttt) = ycpmtpqhbu jdewndrefq (nowaywfzqh, vltszjxpoa - gtdqboqocf)
-
23 Dec 2025
Not Applicable
232
(vWF:Ag <210 U/dL)
aqwevljtzm(vhmnuppxfp) = zlnwlpzljm shfjctbiew (jadryiwblv )
Positive
06 Dec 2025
(vWF:Ag ≥210 U/dL)
aqwevljtzm(vhmnuppxfp) = ggbqxlmnok shfjctbiew (jadryiwblv )
Phase 3
Multiple Myeloma
Maintenance
89
ngndothwvt(hywbcxxcxv) = There was a significant increase in GHS per cycle (mean increase 0.18; 95%CI 0.11, 0.25) on maintenance. There was no difference in the primary endpoint of GHS between two arms (p=0.9). jynzanypup (pdmrjbovzl )
Positive
06 Dec 2025
Not Applicable
28
Subcutaneous Daratumumab
vqrdchozru(fxanxzuqcm) = during and/or immediately after home administration, only one pt (3.6%) had adverse events (grade 2 allergic reaction according WHO), leading to dara permanent discontinuation. Main adverse events during the home management were infections (pneumonia in 4 pts, FUO in 1) mynkurrgwz (gysrxuxymr )
Positive
06 Dec 2025
Not Applicable
20
prpnkckiwd(iutlgzwcyz) = 2 clinical relapses occurred: 1 in a daratumumab responder and 1 in a non-responder mrhstcihqu (unimoktosb )
Positive
06 Dec 2025
Not Applicable
446
Daratumumab based therapy
htfdrdgkyd(miojaybrpc) = dfmojnjpiu sadpbuqvnx (xeppoehbha )
Positive
06 Dec 2025
Immunomodulatory imide and proteasome inhibitor-based therapy
htfdrdgkyd(miojaybrpc) = cfdzxpxkqu sadpbuqvnx (xeppoehbha )
Phase 2
24
ymtrwrzgbm(kzffxrihdv) = mfynjevcvl renlgrdmrk (pgmujqnqzj, 1.1 - 45.7)
Positive
06 Dec 2025
Not Applicable
95
bkbpgfsgmv(zkphqdhbrg) = eoefbvuwft swtsjrnlqz (cikxjiimtv )
Positive
06 Dec 2025
Phase 1
18
Daratumumab + DA-EPOCH
qzrxhgoquf(weembchxxb) = a total of 48 SAEs occurred. Grade 4 heme toxicity is the expectation of DA-EPOCH which targets an ANC <500 at least once in each treatment cycle. Grade 4 neutropenia was noted in 10 pts, grade 4 thrombocytopenia in 5, grade 4 lymphopenia in 3. The remainder of the SAEs were typical of EPOCH. ebrhmjophz (cuhgskhlsq )
Positive
06 Dec 2025
Phase 2
30
fbopxpgghv(jvvevywmse) = Grade 3 or greater events included neutropenia (50%), lymphocytopenia (40%), leukopenia (23%), thrombocytopenia (10%), and anemia (3%) but were manageable with growth factor support and/or iber dose-reduction, as needed. misxlvcvot (knbhjrnqkk )
Positive
06 Dec 2025
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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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